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Clinical and Experimental Rheumatology ; 40(10):84, 2022.
Article in English | EMBASE | ID: covidwho-2067776


Objectives. To investigate the safety and efficacy of SARS-Cov-2 vaccination in a large international cohort of patients with primary Sjogren syndrome due to scarcity of data in this population. Methods. By the first week of May 2021, all Big Data Sjogren Consortium centers had been contacted and asked for Registry patients to be included in the study if they had received at least one dose of any SARS-CoV-2 vaccine. The in-charge physician asked patients about local and systemic reactogenicity, using a pre-defined electronic questionnaire to collect epidemiologic data, COVID 19 vaccination data, and COVID 19 vaccination side effects. Adverse events were defined as those reported by the patient at the site of injection within 7 days from vaccination (reactogenicity) as local adverse events, systemic symptoms as systemic side effects, and postvaccination AEs of special interest related to SS as SS flares. Results. The vaccination data of 1237 patients (1170 women, with a mean age at diagnosis of primary SjS of 50.5 13.2) were received. A total of 835 patients (67 percent) reported any adverse event, including local (53 percent) and systemic (50 percent) AEs. Subjective symptoms (63%) were the most common local AEs, followed by objective signs at the injection site (16%) and general symptoms were the most commonly reported systemic AEs (46 percent), followed by musculoskeletal (25 percent), gastrointestinal (9 percent), cardiopulmonary (3 percent), and neurological (2 percent). People under 60 years old had a higher risk of developing AE after vaccination (OR 2.48, CI 95 1.89-3.27 percent), as did those with low systemic SS activity (OR 1.62, CI 95 1.22-2.15) and those who received mRNA vaccines, according to a multivariate analysis (OR 1.57, CI 95 percent 1.12- 2.18). The risk of developing systemic AEs was also higher in women (OR 2.85, CI 95 percent 1.60-5.2346), White people (OR 1.73, CI 95 1.14-2.65), and those who received a deficient vaccination regimen (OR 1.78, CI 95 1.12-2.88 percent). In addition to 141 (11%) patients who reported a significant worsening/exacerbation of their pre-vaccination sicca symptoms as a result of post-vaccination SS flares, 15 (1.2%) patients (13 women, mean age at vaccination 41.9 years) reported active involvement in the glandular (n=8), articular (n=7), cutaneous (n=6), pulmonary (n=2), and peripheral nervous system (n=1) domains as post-vaccination systemic flare. All side effects and flares subsided within 1-3 weeks, with no lasting effects or deaths. In terms of vaccination efficacy, breakthrough SARS-CoV-2 infection was confirmed after vaccination in three (0.24 percent) patients, all of whom recovered completely, and positive anti-SARS-Cov-2 antibodies were detected in approximately 95 percent of vaccinated SjS patients, according to data available. Conclusions. SARS-CoV-2 vaccination in patients with primary SjS, like other vaccines with adequate response and no safety signals, raised no concerns about the vaccine's efficacy or safety.

Clinical and Experimental Rheumatology ; 40(10):83-84, 2022.
Article in English | EMBASE | ID: covidwho-2067774


Objectives. To determine characteristics associated with a more severe COVID-19 outcome in people with Sjogren's disease (SJD). Methods. People with SJD and COVID-19 reported to two international registries (Sjogren Big Data Consortium and COVID-19 Global Rheumatology Alliance) from March 2020 to October 2021 were included. An ordinal COVID-19 severity scale was defined: (1) not hospitalized, (2) hospitalized with no ventilation, (3) hospitalized requiring non-invasive ventilation, (4) hospitalized requiring invasive ventilation, and (5) death. Odds ratios (OR) were estimated using a multivariable ordinal logistic regression model adjusted for age, sex, comorbidities and anti-rheumatic medications included as covariates. Results. A total of 898 people with SJD were included (825 (91.8%) women, mean age SARS-CoV-2 infection diagnosis: 55.5 years), including 652 patients with primary SJD and 246 with other associated systemic rheumatic diseases. 33.9% were hospitalized, 14.5% required ventilation, and 4.3% died. In the multivariable model, older age (OR 1.03, 95% CI 1.02 to 1.05), male sex (OR 1.81, 95% CI 1.10 to 2.92), two or more comorbidities (OR 2.99, 95% CI 1.92 to 4.67;vs none), baseline therapy with corticosteroids (OR 2.04, 95% CI 1.20 to 3.46), immunosuppressive agents (OR 2.09, 95% CI 1.30 to 3.38) and B-cell depleting agents (OR 5.38, 95% CI 2.77 to 10.47) were associated with worse outcomes (reference for all medications: hydroxychloroquine only). Conclusions. More severe COVID-19 outcomes in individuals with Sjogren's are largely driven by demographic factors and baseline comorbidities. Patients using immunosuppressants, especially rituximab, also experienced more severe outcomes.

Clinical & Experimental Rheumatology ; 05:05, 2021.
Article in English | MEDLINE | ID: covidwho-1231708


Systemic autoimmune diseases (SAD) are a heterogeneous group of diseases with a common aetiopathogenic basis affecting all ages characterised by a systemic phenotypic expression with a wide range of severity and outcomes that often require immunosuppressive therapies, leaving patients at high risk of infection. Knowledge of the impact of COVID-19 in patients with SAD is limited because most are included in studies carried out in patients with autoimmune and rheumatic diseases (mainly inflammatory arthritis). Most studies supported an increased risk of SARS-Cov-2 infection in patients with AD and SAD. Although case-control studies reported no significant differences in the rate of poor outcomes between patients with and without AD, large population-based studies analysing baseline risk factors reported a 2-3 times higher rate of poor outcomes in patients with AD, especially in those with SAD. Individual risk factors associated with poor outcomes included gender male, older age, and underlying comorbidities and therapies (glucocorticoids, sulfasalazine, immunosuppressants and rituximab). Patients with SAD had less favourable COVID-19 outcomes than those with inflammatory arthritis, possibly due to a differentiated underlying therapeutic approach (glucocorticoids, immunosuppressants and B-cell depleting agents for most SAD, anti-cytokine therapies and JAK inhibitors for inflammatory arthritis). Despite the limited evidence, most studies suggest that patients with SAD have an increased risk of a worse evolution of SARS-CoV-2 infection, including a greater risk of hospitalisation/ICU admission and worse survival rates and, therefore, should be considered a high-risk group for COVID-19.